TReatment of Atrial Fibrillation With Dual dEfibrillator in Heart Failure Patients

Demonstrate the efficacy of the device-based managed therapy to treat atrial tachycardia and fibrillation (AT/AF) in patients with CHF indication for implant of a CRT defibrillator and to demonstrate the advantage of automatic electrical therapy of atrial arrhythmias compared to an in-hospital approach for treatment of symptomatic AT/AF.

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Key information

Conditions

Heart Failure, Congestive Cardiovascular Diseases Heart Diseases Heart Failure

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Istituto di Clinica Medica I° e Cardiologia A.O.C., Careggi, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

chronic symptomatic HF despite stable, optimal drug therapy
indication for a cardiac resynchronisation device with defibrillator backup according to current guidelines
patients implanted with cardiac resynchronization device with dual (atrial and ventricular) defibrillation capabilities

Exclusion criteria

Chronic atrial fibrillation
Valvular disease
patients who underwent or are planned for ablation of atrial fibrillation
cerebral vascular accident/transient ischemic attack within 12 months from implant which lead to relevant impairment
preexisting unipolar pacemaker

Treatment and study plan

Dual (atrial and ventricular) implantable defibrillator

Device

The devices automatically applies therapy (shock) for atrial fibrillation, when atrial fibrillation is confirmed.

Primary outcomes

Unplanned Hospital Admissions for Cardiac Reasons OR Death of Cardiovascular Causes OR Progression to Chronic Atrial Fibrillation

Time frame: 3 years from randomization (39 months total)

Sponsors and collaborators

Lead sponsor

Boston Scientific Corporation

Industry

Registry information

Acronym: TRADE HF

Important dates

Study start: 2006
Primary completion: 2012
Study completion: 2012
First posted: Jun 28, 2006
Registry last updated: Mar 28, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed